MAUDE Adverse Event Report: IRIDEX CORPORATION CYCLO G6 LASER SYSTEM; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number	66245
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient experiencing macular holes during treatment with a cyclo g6 laser system.Based on the information provided, it appears the treatment was performed within specifications.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Based on similar reported events, the most likely cause of the issue is suspected to be contamination (e.G.Blood, tissue or betadine) on the probe tip when the laser was activated or laser activation when the probe is over pigmented conjunctival tissue.Engineering failure analysis could not be performed because the device was not returned for evaluation.Iridex will continue to follow-up with the doctor for information regarding patient recovery.
Event or Problem Description
Iridex became aware of a patient experiencing macular holes during treatment with a cyclo g6 laser system.Based on the information provided, it appears the treatment was performed within specifications.Based on similar reported events, the most likely cause of the issue is suspected to be contamination (e.G.Blood, tissue or betadine) on the probe tip when the laser was activated or laser activation when the probe is over pigmented conjunctival tissue.The micropulse p3 ifu contains instructions for inspecting and cleaning the device tip during use, and the ifu contains the warning that "contamination of the device tip with blood or tissue of the fiber optic by blood or tissue char can result in surface burns in the eye.".
Additional Manufacturer Narrative
This follow-up report is provided to update the following: 1) part b: b5 -product problem section was updated.2) report c: is this a combination product - no 3) report d: updates to section d8, d9, d4 4) part h: update to include that this a correction and additional information report 5) part d: updated this section with the udi number.6) part e: updates to the initial reporter section with information regarding the complainant.Note: patient information was not provided, therefore part a is not filled out.

• Brand Name: CYCLO G6 LASER SYSTEM
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave.; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer Contact: madhumita srikanth ; 1212 terra bella ave; mountain view, CA 94043-9149 ; 6502189149
• MDR Report Key: 14528297
• Report Number: 2939653-2022-00013
• Device Sequence Number: 5164771
• Product Code: HQF
• UDI-Device Identifier: 00813125015220
• UDI-Public: 0813125015220
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 66245
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown